Effects of Breast Milk Simulated Infant Formula

Not Applicable

Completed

• Conditions: Breast Milk; Infant Formula
• Interventions: Other: Breast milk; Other: Yashili Infant formula, Ruibuen®; Other: Kieember Infant formula, Ruibuen®

• Registration Number: NCT05295030
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Objective：The aim of this trial is to assess effects of Kieember and Yashili infant formula on body growth, behavior development, intestinal comfort, infectious diseases, allergic diseases, the absorption of nutrients and gut microbiota as compared to breast-milk in term infants aged 0-3 months.

Participants：144 healthy term infants aged less than 30 days at entry to study. Study Design: A open-label,parallel, controlled trial.

Arms, Groups, and Intervention: (1) Breast milk-fed group: fed with human breast milk; (2) Breast Milk Simulated Formula Group：fed with breast milk simulated infant formula (Ruibuen®Kieember, Phase I); (3) Traditional Formula Group: fed with traditional infant formula (Ruibuen®Yashili, Phase I).

Intervention Duration: 90 days.

Visits: 1month and 3month old.

Outcome measures: (1)Biochemical detection of feces (total fat, fatty acids, calcium, nitrogen);(2)Stool characteristics (frequency, color, volume, and stool consistency);(3)Anthropometric parameters (body length, body weight, and head circumferences);(4)Temperament and adaptive behavior;(5)Gut microbiota;(6)General health and wellbeing;(7)concomitant medications and adverse events.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-13
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-24
• Study Start: 2022-04-10
• Primary Completion: 2023-12-25
• Study Completion: 2023-12-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

• Term infant: Born at 37-42 gestation weeks
• Birth weight: 2500-4000g (appropriate for gestational age)
• The infant is in good health and Apgar after 5 minutes >7
• The mother had unequivocally decided not to breastfeed (for formula fed infants) or to breastfeed (for human milk fed infants)
• age at the enrollment: less than 30 days

Exclusion Criteria

• The mother is unable to take care of her infant on account of health condition (psychological or physical) or socioeconomic problems
• The infant is born with a congenital malformation or chromosome abnormality with a clinical significance
• The infant suffers from a disease requiring mechanical ventilation or medication in the first week of life (not including applying phototherapy of blue to cure neonatal jaundice)
• The infant whose feeding or normal metabolism is affected by any suspected or unknown metabolic factors or physical limitations
• The infant has been breastfed for more than 2 weeks (for formula fed infants)
• Twins or multiple births

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breast Milk-Fed Group	Breast milk	The infants will be breastfed during the study.
Traditional Formula Group	Yashili Infant formula, Ruibuen®	Yashili Infant formula, Ruibuen®: Infants will be fed Yashili infant formula (Phase I) from baseline (1 month old) to 3 month old.
Breast Milk Simulated Formula Group	Kieember Infant formula, Ruibuen®	Kieember Infant formula, Ruibuen®: Infants will be fed Kieember infant formula(Phase I) from baseline (1 month old) to 3 month old.

Primary Outcome Measures

Name	Time	Method
Average Change Rate of Gut Microbiota Pattern Score from 1month to 3 month	1,3 months	Slope of change at 1 and 3 month in gut microbiota pattern score from 16S RNA sequencing.
Average Change Rate of body weight from 1month to 3 month	1,3 months	Slope of change at 1 and 3 month in body weigh.
Average Change Rate of Fecal Residual Fatty Acid from 1month to 3 month	1,3 months	Slope of change at 1 and 3 month in Fecal Residual Fatty Acid.
Average Change Rate of Fecal Residual Nitrogen from 1month to 3 month	1,3 months	Slope of change at 1 and 3 month in Fecal Residual Nitrogen.
Average Change Rate of body length from 1month to 3 month	1,3 months	Slope of change at 1 and 3 month in body length.
Average Change Rate of Fecal Residual Calcium from 1month to 3 month	1,3 months	Slope of change at 1 and 3 month in fecal residual calcium.
Average Change Rate of head circumferences from 1month to 3 month	1,3 months	Slope of change at 1 and 3 month in head circumferences.

Secondary Outcome Measures

Name	Time	Method
Average Change Rate of Stool Characteristic Index from 1month to 3 month	1,3 months	Slope of change at 1 and 3 month in Stool Characteristic Index: calculated by using stool color (using sample pictures), stool shape (using sample pictures), and frequency.
Average Change Rate of Temperament Score from 1month to 3 month	1,3 months	Slope of change at 1 and 3 month in Temperament Score assessed by the Early Infant Temperament Scale
Average Change Rate of an Index of General health and wellbeing from 1month to 3 month	1,3 months	Slope of change at 1 and 3 month in Index of General health and wellbeing, calculated from diseases (cold, diarrhea,infectious diseases), doctor visits, concomitant medications,etc.

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China